You Have No Power to Control State Drug Authorities: HC to Govt

New Delhi

Delhi High Court today said the government's decision to ban around 344 fixed dose combinations (FDCs) was apparently taken as it could not take action those companies making such medicines with licences from state authorities.

"It appears that since you do not have power to control your state licensing authorities, you are taking this action. It all boils down to this that you have exercised this power as you do not have power to take action against those operating without valid license from the Drugs Controller General of India (DCGI)..

"That is what I feel," Justice Rajiv Sahai Endlaw said adding there was a "lacunae" in the system if state authorities were not under control of DCGI.

The observation came after the court heard arguments of Additional Solicitor General (ASG) Sanjay Jain, appearing for the Centre, who said there were no valid licences for making any of the banned FDCs and added it was difficult to implement any action at state level.

However, the ASG also said the lack of approval for these FDCs were a secondary issue and the primary focus was that it "lacked safety and efficacy" and thus, "ban was the only answer".

Opposing the arguments of the government, senior advocate Kapil Sibal, appearing for Pfizer, said no reason was given for banning the FDCs other than saying that these combinations were not rational and lacked therapeutic justification.

He also wondered whom the government was promoting and, in a lighter vein, remarked "Patanjali is becoming more famous nowadays".

When the government was saying these combinations in current quantities are not safe, then it should have said what combinations in what quantity were safe, Sibal said.

The ASG, seeking lifting of the stay on the ban, said thousands of FDCs were under scanner but only 344 were banned as "there was no therapeutic justification for them".

He said that in India "general tendency of medical practitioners is to take the easy route. So they prescribe what is already available in a fixed dose."

To this, the court said,"This cannot be an argument. Then why not say they were prohibited from manufacturing" and added that if someone was manufacturing without approval then action has to be taken against them.

"What you have done is you have banned FDCs whether approval exists or not," it added.

The court sought a list showing which of the petitioner drugs companies have got licences from DCGI and which ones from state bodies. It listed the matters for further hearing tomorrow.

The companies, which include Pfizer, Glenmark, Procter and Gamble (P&G) and Cipla, have challenged the government's March 10 decision to ban 344 FDCs. The decision was stayed in each individual case by the court as an interim measure which still continues.

The court also sought a list of those FDCs which were held to be rational by the government's expert panel but were still banned and those that were being manufactured since before 1988.

The drug companies, during arguments, said the expert committee was set up to look into licences granted by state authorities and claimed that the government, in order to ban drugs approved by state bodies, banned those approved by DCGI.

The companies claimed that the panel was not even a statutory body and thus, there was non-application of mind by the government whose action was "outside the statute" and as a result the interim stay be not lifted.

Meanwhile, DCGI told the court that one of the ingredients in Corex cough syrup was codeine which was not available separately as a syrup in the market. This was the case with majority of the affected FDC drugs, it added.

DCGI also said some FDCs are made only as a promotional practice and there was no other incentive for doing so.

The DCGI said when a FDC was available in the market, doctors felt "compelled" to prescribe that instead of prescribing the ingredients separately in the required dosage.

Pursuant to the court's interim stay order, some well- known medicines on which the ban on sale was lifted were Pfizer's Corex cough syrup, P&G's Vicks Action 500 extra, Glaxo's Piriton expectorant, Reckitt's D'Cold, Piramal's Saridon, Glenmark's Ascoril and Alex cough syrups, Abbott's Phensedyl cough syrup and Alembic's Glycodin cough syrup.

Government had banned 344 FDCs on the ground that they involve "risk" to humans and safer alternatives were available.

As per the notification, "On the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country."

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